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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Urinary Retention (2119); Malaise (2359); Ambulation Difficulties (2544); Constipation (3274)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter. Product id: 8780, serial/lot #: (b)(4), ubd: 16-jan-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient representative (friend/family member of the patient) regarding a patient who was receiving a morphine of an unknown concentration at an unknown dose rate via an implantable pump for spinal pain. It was reported that the patient previously had a catheter revision performed on (b)(6) 2020 because their previous catheter had a kink in it, and it took the physician 4 hours to do the revision. Refer also the mfr report # 3004209178-2020-04396 regarding a prior event. It was further reported that since the revision, the patient had been sick and has had weakness in their legs and couldn't walk very well. The patient had also been in the hospital three times since then. The patient had a pump refill in (b)(6) 2020 and two days later they were in the hospital with worse leg weakness. It was noted that the physician told them that this incident was not related to the fill. The patient¿s left leg was weak, and their right leg had no strength. The patient could not pick up his leg. They had to use a hoyer lift to lift the patient as the patient had no use of their legs. It was further noted that the patient also had no inkling that his bowels were moving and the patient had to have a catheter because he could not urinate. The patient had not gotten the relief that they had prior to the revision. The reporter was questing if the pump or catheter could be causing the symptoms. Both the reporter and the patient wanted the pump to be removed and they were looking for a physician to remove the pump. No further patient complications have been reported as a result of this event.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10971878
MDR Text Key220644399
Report Number3004209178-2020-21437
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
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